Document Details

Generated Narrative: Bundle TEST PURPOSES ONLY - trajenta

Document Subject

Generated Narrative: MedicinalProductDefinition mpc69b74a6bb42f26caea2acbf89949208

identifier: http://ema.europa.eu/identifier/EU/1/11/707/001 (10 × 1 tablets)

type: Medicinal Product

domain: Human use

status: active

legalStatusOfSupply: Medicinal product subject to medical prescription

name

productName: Trajenta 5 mg film-coated tablets

type: Full name

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part: nan

type: Invented name part

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part: nan

type: Scientific name part

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part: nan

type: Strength part

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type: Pharmaceutical dose form part

Usages

-	Country	Jurisdiction	Language
*	EU	EU	en

Document Content

Generated Narrative: Composition composition-en-c69b74a6bb42f26caea2acbf89949208

identifier: http://ema.europa.eu/identifier/EU/1/11/707/001 (10 × 1 tablets)

status: Final

type: Package Leaflet

category: Raw

date: 2022-02-16 13:28:17+0000

author: Organization ACME industry

title: TEST PURPOSES ONLY - trajenta

Attesters

What is in this leaflet:

1. What Trajenta is and what it is used for
2. What you need to know before you take Trajenta
3. How to take Trajenta
4. Possible side effects
5. How to store Trajenta
6. Contents of the pack and other information.

Trajenta contains the active substance linagliptin which belongs to a group of medicines called oral anti-diabetics . Oral anti-diabetics are used to treat high blood sugar levels. They work by helping the body reduce the level of sugar in your blood. Trajenta is used for type 2 diabetes in adults, if the disease cannot be adequately controlled with one oral anti-diabetic medicine (metformin or sulphonylureas) or diet and exercise alone. Trajenta may be used together with other anti-diabetic medicines e.g. metformin, sulphonylureas (e.g. glimepiride, glipizide), empagliflozin, or insulin. It is important to keep following the advice about diet and exercise that you have been given by your doctor or nurse.

Do not take Trajenta

if you are allergic to linagliptin or any of the other ingredients of this medicine (listed in section 6). Warnings and precautions Talk to your doctor, pharmacist or nurse before taking Trajenta if you:

have type 1 diabetes (your body does not produce any insulin) or diabetic ketoacidosis (a complication of diabetes with high blood sugar, rapid weight loss, nausea or vomiting). Trajenta should not be used to treat these conditions.

are taking an anti-diabetic medicine known as a sulphonylurea (e.g. glimepiride, glipizide), your doctor may want to reduce your dose of sulphonylurea when you take it together with Trajenta in order to avoid your blood sugar going too low.

have had allergic reactions to any other medicines that you take to control the amount of sugar in your blood.

have or have had a disease of the pancreas. If you have symptoms of acute pancreatitis, like persistent, severe stomach ache (abdominal pain), you should consult your doctor. If you encounter blistering of the skin it may be a sign for a condition called bullous pemphigoid. Your doctor may ask you to stop Trajenta. Diabetic skin lesions are a common complication of diabetes. You are advised to follow the recommendations for skin and foot care that you are given by your doctor or nurse. Children and adolescents Trajenta is not recommended for children and adolescents under 18 years. It is not effective in children and adolescents between the ages of 10 and 17 years. It is not known if this medicine is safe and effective when used in children younger than 10 years. Other medicines and Trajenta Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. In particular, you should tell your doctor if you are using medicines containing any of the following active substances:

Carbamazepine, phenobarbital or phenytoin. These may be used to control fits (seizures) or chronic pain.

Rifampicin. This is an antibiotic used to treat infections such as tuberculosis. Pregnancy and breast-feeding If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. It is unknown if Trajenta is harmful to the unborn child. Therefore, it is preferable to avoid using Trajenta if you are pregnant. It is not known if Trajenta passes into human breast milk. A decision must be made by your doctor whether to discontinue breast-feeding or to discontinue/abstain from Trajenta therapy. Driving and using machines Trajenta has no or negligible influence on the ability to drive and use machines. Taking Trajenta in combination with medicines called sulphonylureas and/or insulin can cause too low blood sugar levels (hypoglycaemia), which may affect your ability to drive and use machines or work without safe foothold. However, more frequent blood glucose testing might be recommended to minimise the risk for hypoglycaemia, especially when Trajenta is combined with sulphonylurea and/or insulin.

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure. The recommended dose of Trajenta is one 5 mg tablet once a day. You can take Trajenta with or without food. Your doctor may prescribe Trajenta together with another oral anti-diabetic medicine. Remember to take all medicines as directed by your doctor to achieve the best results for your health. If you take more Trajenta than you should If you take more Trajenta than you should, talk to a doctor immediately. If you forget to take Trajenta

If you forget to take a dose of Trajenta, take it as soon as you remember it. However, if it is nearly time for the next dose, skip the missed dose.

Do not take a double dose to make up for a forgotten dose. Never take two doses on the same day. If you stop taking Trajenta Do not stop taking Trajenta without first consulting your doctor. Your blood sugar levels may increase when you stop taking Trajenta. If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.

Like all medicines, this medicine can cause side effects, although not everybody gets them. Some symptoms need immediate medical attention You should stop taking Trajenta and see your doctor immediately if you experience the following symptoms of low blood sugar: trembling, sweating, anxiety, blurred vision, tingling lips, paleness, mood change or confusion (hypoglycaemia). Hypoglycaemia (frequency: very common, may affect more than 1 in 10 people) is an identified side effect when Trajenta is taken together with metformin and a sulphonylurea. Some patients have experienced allergic reactions (hypersensitivity; frequency uncommon, may affect up to 1 in 100 people) while taking Trajenta alone or in combination with other medicinal products for the treatment of diabetes, which may be serious, including wheezing and shortness of breath (bronchial hyperreactivity; frequency not known, frequency cannot be estimated from the available data). Some patients experienced rash (frequency uncommon), hives (urticaria; frequency rare, may affect up to 1 in 1 000 people), and swelling of the face, lips, tongue, and throat that may cause difficulty in breathing or swallowing (angioedema; frequency rare). If you experience any of the signs of illness mentioned above, stop taking Trajenta and call your doctor right away. Your doctor may prescribe a medicine to treat your allergic reaction and a different medicine for your diabetes. Some patients have experienced inflammation of the pancreas (pancreatitis; frequency rare, may affect up to 1 in 1 000 people) while taking Trajenta alone or in combination with other medicinal products for the treatment of diabetes. STOP taking Trajenta and contact a doctor immediately if you notice any of the following serious side effects:

Severe and persistent pain in the abdomen (stomach area) which might reach through to your back, as well as nausea and vomiting, as it could be a sign of an inflamed pancreas (pancreatitis). Some patients have had the following side effects while taking Trajenta alone or in combination with other medicinal products for the treatment of diabetes:

Common: level of lipase in the blood increased.

Uncommon: inflamed nose or throat (nasopharyngitis), cough, constipation (in combination with insulin), level of amylase in the blood increased.

Rare: blistering of skin (bullous pemphigoid). Reporting of side effects If you get any side effects talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.

Keep this medicine out of the sight and reach of children. Do not use this medicine after the expiry date which is stated on the blister and the carton after EXP. The expiry date refers to the last day of that month. This medicine does not require any special storage conditions. Do not use Trajenta if the package is damaged or shows signs of tampering. Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

What Trajenta contains

The active substance is linagliptin Each film-coated tablet (tablet) contains 5 mg of linagliptin

The other ingredients are Tablet core: Mannitol, pregelatinised starch (maize), maize starch, copovidone, magnesium stearate Film coating: Hypromellose, titanium dioxide (E171), talc, macrogol (6000), iron oxide red (E172) What Trajenta looks like and contents of the pack

Trajenta 5 mg tablets are 8 mm diameter round, light red film-coated tablets debossed with D5 on one side and the Boehringer Ingelheim logo on the other.

Trajenta is available in perforated aluminium/aluminium unit dose blisters. The pack sizes are 10 1, 14 1, 28 1, 30 1, 56 1, 60 1, 84 1, 90 1, 98 1, 100 1 and 120 1 tablets. Not all pack sizes may be marketed in your country. Marketing Authorisation Holder Boehringer Ingelheim International GmbH Binger Strasse 55216 Ingelheim am Rhein Germany Manufacturer Boehringer Ingelheim Pharma GmbH & Co. KG Binger Strasse 55216 Ingelheim am Rhein Germany Boehringer Ingelheim Hellas Single Member S.A. 5th km Paiania Markopoulo Koropi Attiki, 19Greece Dragenopharm Apotheker P schl GmbH G llstra e 1 84529 Tittmoning Germany For any information about this medicine, please contact the local representatives of the Marketing Authorisation Holder: Belgi /Belgique/Belgien Boehringer Ingelheim SComm T l/Tel: +32 2 773 33 Lietuva Boehringer Ingelheim RCV GmbH & Co KG Lietuvos filialas Tel: +370 5 2595

: +359 2 958 79 Luxembourg/Luxemburg Boehringer Ingelheim SComm T l/Tel: +32 2 773 33 esk republika Boehringer Ingelheim spol. s r.o. Tel: +420 234 655 Magyarorsz g Boehringer Ingelheim RCV GmbH & Co KG Magyarorsz gi Fi ktelepe Tel.: +36 1 299 8Danmark Boehringer Ingelheim Danmark A/S Tlf: +45 39 15 88 Malta Boehringer Ingelheim Ireland Ltd. Tel: +353 1 295 9Deutschland Boehringer Ingelheim Pharma GmbH & Co. KG Tel: +49 (0) 800 77 90 Nederland Boehringer Ingelheim B.V. Tel: +31 (0) 800 22 55 Eesti Boehringer Ingelheim RCV GmbH & Co KG Eesti filiaal Tel: +372 60 80 Norge Boehringer Ingelheim Norway KS Tlf: +47 66 76 13
Boehringer Ingelheim . . T : +30 2 10 89 06 sterreich Boehringer Ingelheim RCV GmbH & Co KG Tel: +43 1 80 105-7Espa a Boehringer Ingelheim Espa a, S.A. Tel: +34 93 404 51 Polska Boehringer Ingelheim Sp.zo.o. Tel.: +48 22 699 0 France Boehringer Ingelheim France S.A.S. T l: +33 3 26 50 45 Portugal Boehringer Ingelheim Portugal, Lda. Tel: +351 21 313 53 Hrvatska Boehringer Ingelheim Zagreb d.o.o. Tel: +385 1 2444 Rom nia Boehringer Ingelheim RCV GmbH & Co KG Viena - Sucursala Bucure ti Tel: +40 21 302 28 Ireland Boehringer Ingelheim Ireland Ltd. Tel: +353 1 295 9Slovenija Boehringer Ingelheim RCV GmbH & Co KG, Podru nica Ljubljana Tel: +386 1 586 40 sland Vistor hf. S mi: +354 535 7Slovensk republika Boehringer Ingelheim RCV GmbH & Co KG, organiza n zlo ka Tel: +421 2 5810 1Italia Boehringer Ingelheim Italia S.p.A. Tel: +39 02 5355 1 Suomi/Finland Boehringer Ingelheim Finland Ky Puh/Tel: +358 10 3102
Boehringer Ingelheim . . T : +30 2 10 89 06 Sverige Boehringer Ingelheim AB Tel: +46 8 721 21 Latvija Boehringer Ingelheim RCV GmbH & Co KG Latvijas fili le Tel: +371 67 240 United Kingdom (Northern Ireland) Boehringer Ingelheim Ireland Ltd. Tel: +353 1 295 9This leaflet was last revised in Detailed information on this medicine is available on the European Medicines Agency web site: